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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Lutonix Long Lesion SFA Cont f/u study


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General
Study Status Completed
Application Number /
Requirement Number		 P130024 S009/ PAS003
Study Name Lutonix Long Lesion SFA Cont f/u study
Device Name LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Continued follow-up
Study Population DCB
Key Study Endpoints the composite of freedom from all-cause peri-procedural (=30 day) death and freedom at 1 year and2 years from the following: index limb amputation and (above or below the ankle) and index limb re-intervention and (2) primary patency at 1 year and 2 years
Follow-up Visits and Length of Follow-up 2 years
yearly
Interim or Final Data Summary
Actual Number of Patients Enrolled 125
DCB Subjects (118)
Control Subjects (7)
Actual Number of Sites Enrolled 14
Patient Follow-up Rate DCB Subjects 89.0% (105/118)
Lost to follow up plus withdrew from study.
Final Safety Findings The primary safety endpoint for the DCB group was 78.7%% (85/108) [69.8, 86.0] and was defined as the composite of freedom from all-cause peri-procedural (less than or equal to 30 day) death and freedom at 1 year from the following: index limb amputation (above or below the ankle) and index limb re-intervention.
Final Effect Findings The primary effectiveness endpoint for the DCB group was DCB group: 58.3% (60/103) [48.1, 67.9] and represents primary patency at 12 months. Primary Patency is defined as Freedom from Clinically-Driven TLR and from Binary Restenosis.
Study Strengths & Weaknesses The strengths of the study include looking at the long lesion length indication and the extended safety follow up. Study weaknesses include the small sample size and lack of control group.
Recommendations for Labeling Changes No


Lutonix Long Lesion SFA Cont f/u study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 02/07/2018 03/07/2018 Overdue/Received
final report 02/07/2019 04/16/2019 Overdue/Received


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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